Is NCT04953897 recruiting in Houston, TX?

Yes, NCT04953897 is currently recruiting participants at its Houston, TX location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Myeloid Leukemia Clinical Trial in Houston, TX

About This Acute Myeloid Leukemia Study in Houston

This is a Phase 1b, multicenter, open-label, PK, and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with severe renal impairment and cancer participants with normal renal function as matched control participants. Adult participants with acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors who are candidates to receive oral decitabine and cedazuridine will be enrolled in this study. Study duration per participant is approximately up to 8 weeks.

Sponsor: Taiho Oncology, Inc.

Who Can Participate

Inclusion Criteria

Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective informed consent before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first treatment cycle.

Participants must have a histologically or cytologically confirmed malignancy as follows:

A solid tumor that is metastatic or unresectable and for which standard life-prolonging measures are not available. or

AML or MDS. or

A hematologic malignancy other than AML or MDS for which standard life-prolonging measures are not available.

For participants with AML/MDS only:

Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) or MDS according to the 2008 World Health Organization (WHO) classification or

Participants with frontline MDS or treatment naïve AML not suitable for induction therapy (e.g., age \>75 years, Eastern Cooperative Oncology Group \[ECOG\] performance ≥2, severe pulmonary disorder, total bilirubin 1.5 × upper limit of normal \[ULN\]); or

Platelet count ≥25,000/per microliter (μL); or

Absolute neutrophil count (ANC) ≥100 cells/μL.

For participants with only hematologic malignancies other than AML or MDS, or solid tumors:

Platelet count ≥100,000/μL; and

ANC ≥1000 cells/μL.

ECOG performance status of 0 to 3.

Adequate hepatic function defined as:

Total or direct bilirubin ≤1.5X upper limit of normal (ULN); and

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5X ULN.

Participants must have a body surface area (BSA)-adjusted CLcr using to the Cockcroft-Gault equation:

Participants without renal impairment (Group B): ≥80 mL/min/1.73m\^²;

Participants with severe renal impairment (Group A): \<30 mL/min/1.73m\^², not requiring dialysis;

CLcr must be stable with \<30% deviation allowed from screening to Day -1 (Baseline). Participants shifting outside the prospected renal function category (normal renal function or severe renal function) on Day-1 Baseline need to be agreed by Taiho medical expert whether they are allowed to remain in the original category that was assessed at screening.

No major surgery within 30 days of first administration of oral decitabine and cedazuridine.

Life expectancy of at least 3 months.

Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.

Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control with low user dependency and must agree not to become pregnant for 6 months after completing treatment.

Male participants with female partners of childbearing potential must agree to use a male condom and advise his partner to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) and must agree not to father a child while receiving treatment with oral decitabine and cedazuridine for at least 3 months after completing treatment.

Exclusion Criteria

Treatment with azacitidine or decitabine within 4 weeks before Screening. Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.

Hospitalization for more than 2 days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection 30 days prior to first dose.

Treatment with any investigational medicinal product (IMP), investigational therapy, chemotherapy, immunotherapy, or targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment, or ongoing clinically significant adverse events from previous treatment.

Concurrent MDS therapies, including lenalidomide, cyclosporine/tacrolimus, granulocyte-colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor, etc. Prior treatment with these agents is permitted, provided that completion is at least 1 week before the first dose of study treatment. Short-term use of G-CSF for febrile neutropenia is permitted at the discretion of the treating physician and should be guided by accepted practice or institutional guidelines. Hematopoietic growth factors will not be routinely used unless cleared by Taiho medical expert.

Administration of live (attenuated) vaccines within 4 weeks before the first administration of oral decitabine and cedazuridine until after the follow-up visit. Other vaccines, e.g., inactivated or ribonucleic acid (RNA)-based, may be administered but should not occur from 7 days before first administration of oral decitabine and cedazuridine until after the follow-up visit.

High medical risk because of other conditions such as uncontrolled systemic diseases, active uncontrolled infections, or comorbidities that may put the participants at risk of not being able to complete 1 cycle of treatment.

Conditions which likely promote delayed ventricular repolarization (QT prolongation):

Corrected QT interval (QTc) using Fridericia's correction (QTcF) at Screening or Day -1 \>470 milliseconds (ms) for males and \>480 ms for females or

History or disposition for torsades des pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or

Concomitant medications that prolong the QT/QTc interval

Cardiac abnormalities or unstable cardiovascular conditions:

Unstable ischemic heart disease or severe heart failure (New York Heart Association Class III or IV) or

Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥ 180 millimeters of mercury (mmHg) and/or diastolic blood pressure ≥ 110 mmHg; current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg).

Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the participants to high risk of noncompliance with the protocol.

In participants with AML/MDS, rapidly progressive or highly proliferative disease or other criteria that render the participants at high risk of requiring intensive cytotoxic chemotherapy within the next 3 months.

Life-threatening illness or severe organ system dysfunction, such as uncontrolled congestive heart failure or chronic obstructive pulmonary disease, or other reasons including laboratory abnormalities, that in the investigator opinion, could compromise the participant safety, interfere with the absorption or metabolism of oral decitabine and cedazuridine, or compromise completion of the study or integrity of the study outcomes.

Untreated central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks before screening.

Participants infected with human immunodeficiency virus (HIV).

Participants with active hepatitis B or hepatitis C infection.

History of alcohol abuse or drug addiction (including soft drugs like cannabis products).

Average intake of more than 24 units of alcohol per week for male participants and 17 units per week for female participants (1 unit of alcohol equals 10 milliliters (mL) of pure alcohol, i.e., approximately 250 mL of beer, 75 mL of wine or 25 mL of spirits).

Donation or loss of more than 500 mL of blood within 60 days prior to the first study drug administration.

Hypersensitivity to decitabine, cedazuridine, or any of the excipients in oral decitabine and cedazuridine.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT04953897) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia Treatment Options in Houston, TX

If you're searching for acute myeloid leukemia treatment options in Houston, TX, this clinical trial (NCT04953897) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute myeloid leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Houston, TX

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